Description

Prinovox is a broad spectrum parasite treatment for dogs, cats and ferrets. It provides protection against lungworm, heartwrom, intestinal roundworms, fleas, lice and mites. Prinovox is easily given by being applied as a "spot-on" treatment to the skin at the back of the neck (where the animal cannot easily lick it off).

- For the treatment and prevention of flea infestation (Ctenocephalides felis),

- The prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis).

Contra-indications

Do not use in kittens under 9 weeks of age.

Do not use in animals that are known to be hypersensitive to the active substances or to any of the excipients.

For ferrets: Do not use Prinovox for large cats (0.8 ml) or Prinovox for dogs (any size).

For dogs, the corresponding “Prinovox for dogs” product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used.

Special warnings for each target species

The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time

Special precautions for use

i) Special precautions for use in animals

The treatment of cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should be based on a risk-benefit assessment.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

Care should be taken that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to groom each other. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.

It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease.

Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat and ferret aged over 6 months, before beginning prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.

In certain individual cats Notoedres cati infestation may be severe. In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

After application do not stroke or groom animals until the application site is dry.

In case of accidental spillage onto skin, wash off immediately with soap and water.

People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation).

In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.

iii) Other precautions

The solvent in the product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

Adverse reactions

Use of the product may result in transient pruritus in cats. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment, neurological signs (most of which are transient) may be observed in very rare cases.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application site.

The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Interactions

During treatment with this veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.

No interactions between this veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Amounts to be administered and administration route

The treatment schedule should be based on individual veterinary diagnosis and on the local epidemiological situation.

Weight of cat (kg)

Pipette size to be used

Volume (ml)

Imidacloprid

(mg/kg bw)

Moxidectin

(mg/kg bw)

< 4kg

Prinovox for small cats and ferrets

0.4ml

Minimum of 10

Minimum of 1

4-8kg

Prinovox for large cats

0.8ml

10-20

1-2

>8kg

Use the appropriate combination of pipettes

Flea treatment and prevention

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine the treatment with this product with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Treatment of ear mite infestation (Otodectes cynotis)

A single dose of the product should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of notoedric mange (Notoedres cati)

A single dose of the product should be administered.

Heartworm prevention

Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with this product, the advice provided above should be considered.

For prevention of heartworm disease, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with this product must be given within 1 month of the last dose of the former medication.

In non-endemic areas there should be no risk of cats having heartworm. Therefore they can be treated without special precautions.

Roundworm and hookworm treatment

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Dosage schedule for FERRETS:

One 0.4 ml pipette of this product should be administered per animal. Do not exceed the recommended dose.

The treatment schedule should be based on the local epidemiological situation.

Flea treatment and prevention

One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be necessary to repeat administration after 2 weeks.

Heartworm prevention

Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with this product, the advice provided above should be considered.

For prevention of heartworm disease, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes.

In non-endemic areas there should be no risk of ferrets having heartworm. Therefore they can be treated without special precautions.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette.

Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the animal to lick the product. Apply only to undamaged skin.

Overdose

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.

Withdrawal periods

Not applicable

Pharmacological particulars

Pharmacodynamic properties

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis. It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

Pharmacokinetic properties

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats. Following absorption from the skin, moxidectin is distributed systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

Pharmaceutical particulars

Excipients

Butylhydroxytoluene E 321

Benzyl alcohol

Propylene carbonate

Major incompatibilities

none known

Shelf life

As packaged: 3 years

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions

The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Contra-indications

Do not use in puppies under 7 weeks of age.

Do not use in animals that are known to be hypersensitive to the active substances or to any of the excipients.

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.

For cats, the corresponding “Prinovox for cat” product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use Prinovox for dogs. Only “Prinovox for small cats and ferrets” (0.4 ml) must be used.

Special warnings for each target species

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time.

The product has not been shown to have an adulticidal effect against D. repens.

Special precautions for use

i) Special precautions for use in animals

The treatment of animals weighing less than 1 kg should be based on a risk-benefit assessment.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.

Care should be taken that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to groom each other. When the product is applied in 3 to 4 separate spots, specific care should be taken to prevent the animal licking the application sites.

This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described under dosage schedule; in particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

The product should not enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of this product has not been evaluated when administered on the same day as an adulticide.

Adverse reactions

-Use of the product may result in transient pruritus in dogs. On rare occasions greasy hair, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment, neurological signs (most of which are transient) may be observed in very rare cases.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application sites.

The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.

A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnea and dyspnea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Interactions

During treatment with this veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.

No interactions between this veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of this veterinary medicinal product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

Amounts to be administered and administration route

The treatment schedule should be based on individual veterinary diagnosis and on the local epidemiological situation.

Flea treatment and prevention

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine the treatment with the product with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Treatment of biting lice (Trichodectes canis)

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of ear mite infestation (Otodectes cynotis)

A single dose of the product should be administered. Loose debris should be gently removed from the external ear canal at each treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis)

A single dose should be administered twice 4 weeks apart.

Treatment of demodicosis (caused by Demodex canis)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, the product can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with this product, the advice provided above should be considered.

For prevention of heartworm disease and cutaneous dirofilariosis, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with this product must be given within 1 month of the last dose of the former medication.

In non-endemic areas there should be no risk of dogs having heartworm. Therefore they can be treated without special precautions.

Treatment of microfilariae (D. immitis)

The product should be administered monthly for two consecutive months.

Reduction of microfilariae ( D. repens)

The product should be administered monthly for four consecutive months. Efficacy against adult worms has not been shown. Adult worms may continue to produce microfilariae.

Treatment and prevention of Angiostrongylus vasorum

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Method of administration

For external use only.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette.

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.

Weight of dog (kg)

Pipette size to be used

Volume

Imidacloprid (mg/kg bw)

Moxidectin (mg/kg bw)

≤4kg

Prinovox for Small Dogs

0.4ml

Minimum of 10

Minimum of 2.5

>4-10kg

Prinovox for medium dogs

1.0ml

10-25

2.5-6.25

>10-25kg

Prinovox for large dogs

2.5ml

10-25

2.5-6.25

>25-40kg

Prinovox for extra large dogs

4.0ml

10-16

2.5-4

>40kg

the appropriate combination of pipettes

Overdose

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.

The product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40 % of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10 % of the recommended dose produced no adverse effects.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.

Withdrawal periods

not applicable

Pharmacological particulars

Pharmacodynamic properties

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis. It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

Pharmacokinetic properties

After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

Pharmaceutical particulars

-

Excipients

Butylhydroxytoluene E321

Benzyl alcohol

Propylene carbonate

Major incompatibilities

None known

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

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